Kornimate/medical-research-clean huggingface dataset:
volume de-escalation in neoadjuvant radiochemotherapy of rectal cancer

Conditions: Toxicity

Summary: the study outlines a clinical prospective protocol consisting of preoperative chemoradiation in locally advanced rectal cancer, without elective pelvic nodal irradiation. the proposal to exclude lateral spaces from the target volume is based on the assumption that the radiological evidence of recurrence in the lateral lymph nodes is shown to be below 5%. in the study all patients underwent an accurate pre-treatment work-up including total body ct, pelvic mri and 18-fluorodeoxyglucose pet/ct, in order to include patients without evidence of disease in lateral lymph nodes. the primary endpoint of the study was the reduction of gastrointestinal toxicity; secondary endpoints were the pathological complete response (pcr), the local control (lc) rate, the overall survival (os) and the disease-free survival (dfs).

patients affected by histologically proven rectal cancer were considered for enrollment in a prospective protocol that included preoperative crt and surgical treatment. all patients underwent pre-treatment work-up (clinical examination, pancolonoscopy with biopsy, total body ct scan, pelvic mri, and whole body 18-fluorodeoxyglucose pet/ct scan). eligible patients had primary resectable ct2-low lying-t3, n0-n1 adenocarcinoma of the rectum, without evidence of disease in lateral lymph nodes. additional eligibility criteria included performance status as well as liver, kidney, and bone marrow function that allowed for long-course crt, older than 18 years, and no distant metastases.

Eligibility criteria:
inclusion criteria: * primary resectable ct2-low lying-t3, n0-n1 adenocarcinoma of the rectum, without evidence of disease in lateral lymph nodes * no distant metastases exclusion criteria: * evidence of disease in lateral lymph nodes * distant metastases
intraoperative aberrometry vs conventional intraocular lens calculation, a prospective study.

Conditions: Intraocular Lens Implantation; Cataract; Humans; Ocular, Refraction

Summary: the goal of this intervention study is to compare prospectively the accuracy of the power calculation between both groups, the intraoperative aberrometry (ora) vs barrett universal ii preoperative calculation (control group) . researchers will compare ora group vs control to see changes in spherical equivalent and uncorrected distance visual acuity

studies have described a small difference between ora (intraoperative aberrometer) and preoperative calculation with latest generation formulas ( barrett universal ii ), the investigators intend to compare both groups prospectively, during the process randomization and blinding of the participants will be made. the investigators will report spherical equivalent and uncorrected distance visual acuity values at 90 days of the postoperative period.

Eligibility criteria:
inclusion criteria: * patients with senile cataract, patients undergoing phacoemulsification, complete biometric profile, axial length calculated by interferometer. exclusion criteria: * glaucoma, uncontrolled diabetic retinopathy, pseudoexfoliation syndrome, aged macular degeneration , dry eye syndrome, other ocular pathologies.

Keywords: biometry aberrometry prospective study
a drug-drug interaction study of oral 1250 mg of vatalinib administered under fasting and fed conditions with a proton-pump inhibitor in healthy sterile or postmenopausal female volunteers

Conditions: Healthy

Summary: this study will determine the effect of acidic drugs such as proton-pump inhibitors on the pharmacokinetics of vatalinib under fasting and fed conditions.


Eligibility criteria:
inclusion criteria * healthy female * surgically sterile or post-menopausal * at least a weight of 50 kg and have a body mass index (bmi) ≤33.0 * non-smokers or those who smoke 25 cigarettes or less per day exclusion criteria * use of certain prescription and over the counter drugs * having received an investigational drug within 30 days prior to dosing * donation of plasma or donation or loss of whole blood prior to administration of the study medication * any clinically significant laboratory tests * abnormal cardiac function * a positive test for hiv, hepatitis b or c * a positive alcohol test or drug test * known allergy to vatalinib or omeprazole * any surgical or medical condition which might significantly alter the absorption, distribution, metabolism and excretion or drugs. other protocol-defined inclusion/exclusion criteria may apply

Keywords: vascular endothelial growth factor receptor (vegf-r) tyrosine kinase inhibitor vatalinib proton-pump inhibitors omeprazole healthy postmenopausal female volunteers
development of post traumatic stress disorder after natural disaster

Conditions: Development of PTSD After Natural Disaster

Summary: a survey (patient self-report) of patients presenting to uab emergency room, outpatient trauma clinics and substance abuse center for symptoms of post-traumatic stress disorder and maladaptive coping responses after the widespread tornado disaster that occurred in alabama in april 2011.


Eligibility criteria:
inclusion criteria: * 19 and older able and willing to complete a questionnaire exclusion criteria: * younger than 19 unwilling or unable to complete a questionnaire
changes of body temperature during shoulder arthroscopy

Conditions: Hypothermia

Summary: the purpose of this study is to compare the effect of electrically heated humidifier on the body temperature during shoulder arthroscopy.

on the control group, use only routine anesthetic respiratory circuit for mechanical ventilation on the comparative group, use electrically heated humidifier for mechanical ventilation and compared the changes of body temperature durgin shoulder artheroscopy.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologist physical status 1 or 2 * 20-60 years old exclusion criteria: * body mass index over 30 kg/m2 * peripheral vascular disease * uncontrolled cardiovascular disease

Keywords: heated circuit body temperature
immunomonitoring and biomarker research in patients with squamous cell anal carcinoma

Conditions: Anal Canal Cancer

Summary: even if squamous cell carcinoma of the anal canal (scca) is a rare disease, its incidence increases worldwide. scca is mostly induced by human papillomavirus (hpv) infections and hpv-related oncoproteins (e6 and e7) are expressed in more than 90% of scca. t stage and n stage are recognized prognostic factors for local and/or distant recurrence in scca patients treated by chemoradiotherapy. in fact, ≥t3 or ≥n1 anal cancers are associated with as high as 50% of disease recurrence rate at 2 years. the university hospital of besançon with the gercor conducted a prospective clinical trial (epitopes hpv02 study) including 69 advanced scca patients and established a new standard of care based on docetaxel, cisplatin and 5-fu (5-fluorouracil) chemotherapy (dcf). among 69 patients treated with dcf regimen, 66 patients were evaluable for efficacy end-points. the objective response rate was 86% including 44% of complete response, and 47% of patients were progression-free at 12 months of follow-up from the first cycle of dcf treatment. thus, the "epitopes-hpv02" trial has demonstrated a high response rate of the dcf regimen with a higher than expected 12 months progression-free survival rate.these results raised the hypothesis of dcf being an immunogenic chemotherapy and in that demonstrating a possibly new role of taxane-based chemotherapy in scca patients. more than 50% of patients in complete remission had a detectable immunological response against peptides derived from hpv oncoproteins (e6 or e7) or from the telomerase antigen (which is transactivated by e6). land study will enroll patients with locally advanced scca enrolled in optimanal clinical trial. optimanal study will assess the feasibility and efficacy to combine nivolumab to mdcf chemotherapy, followed by the standard chemo-radiotherapy, in high risk locally advanced scca patients with t3/t4 n1a or n1b/n1c disease. land study is an exploratory translational study, which will analyze the biological mechanisms of action and our ability to track the immune responses against hpv and telomerase. the investigator group will take advantage of the presence of hpv antigens in most patients to set up a specific immunomonitoring program based on tumor samples and blood-derived lymphocytes to better understand the potential synergisms between immunogenic chemotherapy and anti-pd1 (programmed death-1), and to identify valuable biomarkers of treatment efficacy.


Eligibility criteria:
inclusion criteria: 1. male or female, age ≥18 years, 2. patients enrolled in optimanal trial 3. signed and dated informed consent for land-translational study 4. histologically proved squamous cell anal carcinoma. exclusion criteria: 1. patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study, 2. patient under guardianship, curators or under the protection of justice.

Keywords: locally advanced scca dcf radiotherapy nivolumab biomarkers
phase iii study with teriflunomide versus placebo in patients with first clinical symptom of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the primary objective was to demonstrate the effect of teriflunomide (hmr1726) (14 milligram per day \[mg/day\] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (ms) to clinically definite multiple sclerosis (cdms). the secondary objectives were: * to demonstrate the effect of teriflunomide, in comparison to placebo, on: * reducing conversion to definite multiple sclerosis (dms) * reducing annualized relapse rate (arr) * reducing disease activity/progression as measured by magnetic resonance imaging (mri) * reducing accumulation of disability for at least 12 weeks as measured by the expanded disability status scale (edss) * proportion of disability-free participants as assessed by the edss * reducing participant-reported fatigue * to evaluate the safety and tolerability of teriflunomide * to evaluate the pharmacokinetics (pk) of teriflunomide * optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes

the study consisted of 4 periods: * screening period: up to 4 weeks, * placebo-controlled treatment period: up to 108 weeks (at least 24 weeks for participants who experienced conversion to cdms), * extension treatment period (without placebo-control): the extension period continued until teriflunomide was commercially available in participant's country of residence. * post-treatment washout period: 4 weeks after last treatment intake. the maximal duration of the study period per participant was expected to be 116 weeks if he/she did not continue in the extension treatment period.

Eligibility criteria:
inclusion criteria: * first acute or subacute, well-defined neurological event consistent with demyelination (that is, optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes) * onset of ms symptoms occurring within 90 days of randomization * a screening mri scan with 2 or more t2 lesions at least 3 millimeter (mm) in diameter that are characteristic of ms exclusion criteria: * clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease * significantly impaired bone marrow function * pregnancy or nursing * alcohol or drug abuse * use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment * any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: ms clinically isolated syndrome cis cdms relapses
study to evaluate symptoms in patients treated with nebivolol or metoprolol extended-release (er) for hypertension

Conditions: Hypertension

Summary: the purpose of this study was to compare the tolerability of nebivolol to metoprolol er in a general population of patients with mild to moderate hypertension receiving hydrochlorothiazide (hctz)

this study was an 18-week study to evaluate the tolerability of nebivolol compared to metoprolol er in outpatients with mild to moderate hypertension taking hctz. it is a multi-center, randomized, double blind (db), active-control, parallel-group study, starting with a 4-week hctz run-in phase, followed by a 12-week db treatment phase. patients meeting the entry criteria at the end of run-in are randomized to one of two treatment groups, nebivolol or metoprolol er. up-titration of dose of study drug will occur if needed during the first 4 weeks of the db phase, after which there is an 8-week stable-dose period of treatment. a 2-week double-blind withdrawal phase follows, during which tapering off study drug occurs.

Eligibility criteria:
inclusion criteria: * male or female, ambulatory outpatients * history of hypertension being treated with two medications, one of which must be hctz and the other of which must not be a beta-blocker or clonidine * sbp of 135-155 mm hg and/or dbp of \>85 mm hg at screening (visit 1) * sbp of 140-165 mm hg and dbp \> 90 mmhg at randomization (visit 3) exclusion criteria: * treatment with a beta-blocker or clonidine within 6 months of screening (visit 1) * clinically significant respiratory disease (e.g., bronchial asthma, reactive airways disease, chronic obstructive pulmonary disease) * coronary artery disease requiring treatment with a calcium channel blocker or nitrates * clinically significant cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening (visit 1) * history of severe mental illness (including major depressive disorder, psychosis, dementia, bipolar disorder) within 6 months of screening (visit 1) * use of antipsychotic medication (e.g., dopamine receptor antagonists, serotonin dopamine receptor antagonists) or antidepressants * diabetes mellitus, type i or ii * participation in a previous investigational study of nebivolol at any time * receipt of treatment with an investigational study drug within 30 days of screening (visit 1) * history of hypersensitivity to nebivolol, metoprolol er, other beta-blockers, hctz, or other sulfonamide-derived drugs

Keywords: hypertension nebivolol beta blocker tolerability
achieving medication safety during acute kidney injury

Conditions: Kidney Failure, Acute

Summary: the utilization of clinical decision support (cds) is increasing among healthcare facilities which have implemented computerized physician order entry or electronic medical records. formal prospective evaluation of cds implementations occurs rarely, and misuse or flaws in system design are often unrecognized. retrospective review can identify failures but is too late to make critical corrections or initiate redesign efforts. a real-time surveillance dashboard for high-alert medications integrates externalized cds interactions with relevant medication ordering, administration, and therapeutic monitoring data. the surveillance view of the dashboard displays all currently admitted, eligible patients and provides brief demographics with triggering order, laboratory, and cds failure data to allow prioritization of high-risk scenarios. the patient detail view displays a detailed timeline of orders, order administrations, laboratory values, and cds interactions for an individual patient and allows users to understand provider actions and patient condition changes occurring in conjunction with cds failures. clinical pharmacists' use of the dashboard for patient monitoring and intervention aims to increase the rate and timeliness of intercepted medication errors compared to cpoe-based cds in the setting of acute kidney injury, which affects patients at various points across all hospital units and services and has numerous opportunities for intervention.


Eligibility criteria:
inclusion criteria: * 0.5 mg/dl increase or decrease in serum creatinine within 48 hours * active, recurring order for targeted renally cleared or nephrotoxic medication exclusion criteria: * chronic dialysis * transplant patients

Keywords: medication errors adverse drug events decision support systems, clinical
comparison of non-surgical treatment options for chronic exertional compartment syndrome (cecs)

Conditions: Chronic Exertional Compartment Syndrome

Summary: chronic exertional compartment syndrome (cecs) in the lower leg is a debilitating condition in highly active individuals. pain occurs in 1 or several leg compartments upon an exertional activity, typically running, that quickly dissipates once the activity stopped. surgical fasciotomy is the standard for treating lower leg cecs, but success is variable. complications may occur post-surgery and there is a potential for a repeat procedure. recovery times post-surgery also vary greatly. conservative treatments, such as gait retraining and botulinum toxin injections, are emerging as non-surgical options for the treatment of cecs with success through published case reports and case series. this study aims to evaluate the use of these non-surgical treatment options for cecs in the anterior and lateral leg compartments with a follow up for at least 2 years across multiple study sites.


Eligibility criteria:
inclusion criteria: * active duty service * fluent in speaking and reading english * unable to run 2 miles without producing pain and/or symptoms * difficulty completing the running portion of their service-specific physical training due to pain and/or symptoms in their lower leg * meets clinical diagnostic criteria for cecs of the anterior or lateral compartment per clinical examination (palpation, intramuscular compartment pressure, lower leg mri). exclusion criteria: * prior botulinum injection in the lower leg compartment of the affected limb * prior compartment release of affected lower leg * recent (within the last 6 months) lower limb injury that needed medical intervention * completed formal gait retraining within the last 6 months * allergic to botulinum toxin * pregnant or breastfeeding * medical examination that indicates a condition other than cecs

Keywords: botulinum toxin, gait training, military
japanese omi treatment with kit-positive cells for enhanced regeneration

Conditions: Chronic Heart Failure; Old Myocardial Infarction

Summary: the purpose of this study is to determine the safety and effectiveness of intracoronary infusion of autologous cardiac stem cells in patients with ischemic cardiomyopathy.

this phase i trial will involve 6 patients suffering from chronic ischemic cardiomyopathy and congestive heart failure, to be compared with historical control subjects. this study will be conducted as a collaborative project between the sakakibara heart institute and the cellbank of japan. the trial is designed to assess the safety and effectiveness of autologous administration of 1,000,000 c-kit-positive cardiac stem cells (cscs) via intracoronary route following cultivation. the preliminary eligibility criteria will utilize a left ventricular ejection fraction (lvef) less than 40% measured by echocardiography. during the coronary artery bypass grafting (cabg) surgery, a part (less than 1 gram) of the right atrial appendage (raa) will be harvested and frozen. when the lvef is less than 40% after the cabg surgery, the subject will be enrolled as a candidate for the delivery of cscs, which will be selected from the raa tissue and cultured for a few months for expansion. the outcome will be evaluated by adverse events as well as cardiac functions.

Eligibility criteria:
inclusion criteria: * adult with ability to provide informed consent. * left ventricular ejection fraction less than 40% as evidenced by echocardiogram. * scheduled for elective surgical revascularization within 2 months. exclusion criteria: * positive for hbs-ag, hcv-ab, hiv-ab, or tests for syphilis. * diabetic hba1c greater than 8.5%. * pregnant women. * scheduled for additional interventions including ventriculoplasty.

Keywords: cardiac stem cells c-kit
a post-marketing study evaluating eslicarbazepine acetate (esl) as adjunctive treatment in partial-onset seizures (study e2093-e044-404) (epos)

Conditions: Partial Onset Seizures

Summary: this was a non-interventional prospective study. centres enrolled adult patients with partial-onset seizures with or without secondary generalisation for whom the clinician had decided to initiate eslicarbazepine acetate (esl) as an adjunctive therapy prior to the decision to take part in this study. patients enrolled into the study were not sufficiently controlled with one drug licensed for the use as monotherapy in partial-onset seizures. patients were seen at baseline and then during normal clinical visits at intervals. patients in this study were assessed for efficacy and tolerability at baseline and then at least 3 and 6 months after the baseline.


Eligibility criteria:
inclusion criteria: * the decision to prescribe esl was made by the physician before and independently of his/her decision to include the patient in the study * patients treated with one drug licensed for monotherapy in partial onset seizures * based on the physician's clinical judgment, the patient seizure activity was not controlled sufficiently with a current monotherapy and it was in the patient's best interest to be prescribed adjunctive esl * patient was prescribed esl no longer than 2 weeks before the baseline * treatment with esl was to be commenced in line with the drug's license and eslicarbazepine acetate (esl) summary of product characteristics (spc) * aged 18 years or older * signed written informed consent exclusion criteria: * patients that had started esl outside the approved spc at enrolment * simultaneous participation in an interventional clinical trial

Keywords: esl partial onset seizures retention rate seizure control antiepileptic secondary generalisation